Bradycardia
Conditions
Keywords
Left bundle branch area pacing (LBBAP)
Brief summary
The purpose of this study is to collect and compare the heart's electrical activity data measured by the novel Conduction System Pacing (CSP) Display Research System with data measured via 12 lead electrocardiogram (ECG) from a commercially available, standard of care electro-physiology (EP) monitoring and recording device during the pacemaker implantation. Participants receiving a routine de-novo implantation of a pacemaker for left bundle branch area pacing (LBBAP) will undergo the CSP Display System protocol during the implant procedure.
Detailed description
This feasibility study evaluates the use of the CSP Display Research System during single- or dual-chamber pacemaker implantation for left bundle branch area pacing (LBBAP). The system provides visualization of electrocardiogram data and automatic measurement of left ventricular activation time. Measurements using the CSP Display Research System will be compared with measurements obtained from a standard electrophysiology (EP) recording system used during the implant procedure as part of standard clinical practice. This study also includes exploratory collection of electrocardiogram, intracardiac electrogram, pacemaker marker channel, and left ventricular activation time data during the implant procedure to support future research and algorithm development. These data will be collected for exploratory purposes and do not have a pre-specified evaluation in this study.
Interventions
DEVICECSP Display research system
Research system used during pacemaker implantation to visualize surface electrocardiogram data and automatically measure left ventricular activation time
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is at least 18 years of age * Subject is willing and able to provide written informed consent * Subject is willing and able to comply with the protocol * Subject meets eligibility for de-novo implant of a pacemaker (single or dual chamber) with left bundle branch area pacing (LBBAP) therapy
Exclusion criteria
* Subject is not available to comply with visit schedule * Pregnant or breastfeeding woman (pregnancy test required for woman of child-bearing potential and who are not on a reliable form of birth regulation method or abstinence) * Subject is currently enrolled or planning to enroll in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent study. * Subject meets any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Activation Time (LVAT) | During pacemaker implant procedure | LVAT measured using the CSP Display Research System and a commercial electrophysiology recording system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surface ECG V1 morphology | During pacemaker implant procedure | V1 morphology observed using the CSP Display Research System and a commercial electrophysiology recording system. |
Countries
India
Contacts
CONTACTSr Director - Clinical Research and Medical Science, Medtronic
Outcome results
None listed